The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.

The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.

The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension

Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate.

Treatment failure is defined as "a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee". The date of failure is the actual date of re-intervention.

Presence of infection at the site or in the joint space (e.g. osteomyelitis)

Diagnosis rheumatoidism

Advanced osteoarthritis as judged by the surgeon

Drug and/or alcohol abuse

Hypercalcemia

Known allergy to any of the components of the device (e.g. bovine collagen)

Bleeding disorders of any etiology

Steroidal or immunosuppressive maintenance therapy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01209390